This section highlights FDA-related milestones and regulatory updates for drugs developed by Silexion Therapeutics (SLXN).
Over the past two years, Silexion Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SIL204, SIL-204, and LODER. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
SIL204 FDA Regulatory Timeline and Events
SIL204 is a drug developed by Silexion Therapeutics for the following indication: Across Multiple Cancer Types Beyond Pancreatic Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SIL204
- Announced Date:
- May 14, 2026
- Indication:
- Across Multiple Cancer Types Beyond Pancreatic Cancer
Announcement
Silexion Therapeutics Corp announced positive preclinical findings from an ongoing translational immuno-oncology study evaluating its lead candidate, SIL204, in human KRAS-mutated pancreatic cancer cells.
AI Summary
Silexion Therapeutics Corp. reported encouraging preclinical results from an ongoing translational immuno-oncology study of its lead drug candidate, SIL204, in human KRAS-mutated pancreatic cancer cells. The study focused on a major reason these tumors can hide from the immune system: reduced MHC-I, a molecule that helps cytotoxic T cells identify and attack cancer cells.
Researchers say KRAS-driven tumors often lower MHC-I and weaken antigen presentation, which makes it harder for the immune system to see the cancer. This can also help explain why some tumors resist immune-based treatments. The new findings add to growing evidence that blocking KRAS-linked immune suppression may restore immune recognition and improve anti-tumor activity. Silexion said the results support further development of SIL204 as a possible way to fight KRAS-mutated pancreatic cancer.
Read Announcement- Drug:
- SIL204
- Announced Date:
- April 28, 2026
- Indication:
- Across Multiple Cancer Types Beyond Pancreatic Cancer
Announcement
Silexion Therapeutics Corp announced the recent successful submission of a Clinical Trial Application (CTA) to Germany for its planned Phase 2/3 clinical trial of its lead, small interfering RNA (siRNA) product candidate, SIL204, in patients with locally advanced pancreatic cancer (LAPC).
AI Summary
Silexion Therapeutics Corp announced the recent successful submission of a Clinical Trial Application (CTA) to Germany for its planned Phase 2/3 clinical trial of SIL204, the company’s lead small interfering RNA (siRNA) product candidate, in patients with locally advanced pancreatic cancer (LAPC). The filing marks a move from early development toward larger, late‑stage testing of SIL204, which is being developed to treat tumors that have not spread beyond nearby organs but cannot be removed surgically.
The Phase 2/3 study is intended to evaluate SIL204’s safety and effectiveness in people with LAPC. Following the CTA submission, Silexion will await regulatory review and clearance in Germany before beginning patient enrollment and trial activities. This submission represents an important regulatory milestone for the company and could open the way for further clinical development in Europe if the German authorities permit the trial to proceed.
Read Announcement- Drug:
- SIL204
- Announced Date:
- March 24, 2026
- Indication:
- Across Multiple Cancer Types Beyond Pancreatic Cancer
Announcement
Silexion Therapeutics Corp announced that it has received formal approval from the Israeli Ministry of Health to initiate its Phase 2/3 clinical trial evaluating SIL204 for the treatment of locally advanced pancreatic cancer, following positive preclinical results that demonstrated significant anti-tumor activity in mulitple models alongside successful completion of toxicology studies.
AI Summary
Silexion Therapeutics announced formal approval from the Israeli Ministry of Health to begin a Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer. The clearance follows strong preclinical evidence showing significant anti‑tumor activity across multiple models and completion of required toxicology studies.
Regulators provided constructive engagement on the trial design, supporting the company’s plan to move directly into a combined Phase 2/3 study. Silexion expects to initiate human dosing in the second quarter of 2026, marking a clear step into clinical‑stage development.
SIL204 is a next‑generation RNAi therapy engineered to silence KRAS mutations, which occur in over 90% of pancreatic cancers. Unlike mutation‑specific drugs, SIL204 is designed to target a broad range of KRAS variants, aiming to address multiple KRAS‑driven cancers with high unmet need.
Read Announcement- Drug:
- SIL204
- Announced Date:
- December 16, 2025
- Indication:
- Across Multiple Cancer Types Beyond Pancreatic Cancer
Announcement
Silexion Therapeutics announced the initiation of its regulatory application in Israel for its planned Phase 2/3 clinical trial of SIL204 in patients with locally advanced pancreatic cancer (LAPC), based on the positive Scientific Advice response received from the German Federal Institute for Drugs and Medical Devices (BfArM).
AI Summary
Silexion Therapeutics announced it has started a regulatory application in Israel for its planned Phase 2/3 trial of SIL204 in patients with locally advanced pancreatic cancer (LAPC). The submission follows a positive Scientific Advice response from Germany’s BfArM and is described by the company as a key regulatory milestone as it moves toward a planned trial start in Q2 2026.
The Israel filing is supported by two recent toxicology studies showing no systemic organ toxicity and by strong preclinical results that reported up to 99.7% inhibition of cancer cells across multiple KRAS mutations and tumor types. Silexion plans regulatory filings in Germany and the EU in Q1 2026 and expects to expand to U.S. sites after completing a safety run-in in Israel and Germany.
Silexion is collaborating with Sheba Medical Center for the Israeli portion of the trial. SIL204 is an siRNA therapy designed to silence mutated KRAS, and the Phase 2/3 will test a dual-route approach combining intratumoral and systemic dosing to address primary tumors and metastases.
Read Announcement- Drug:
- SIL204
- Announced Date:
- December 2, 2025
- Indication:
- Across Multiple Cancer Types Beyond Pancreatic Cancer
Announcement
Silexion Therapeutics Corp. announced that it has received formal written Scientific Advice from the German Federal Institute for Drugs and Medical Devices (BfArM) regarding the proposed design of the Company's planned Phase 2/3 clinical trial for SIL204, the Company's lead product candidate for locally advanced pancreatic cancer.
AI Summary
Silexion Therapeutics said it received formal written Scientific Advice from the German Federal Institute for Drugs and Medical Devices (BfArM) about the planned design of its Phase 2/3 trial for SIL204, its lead candidate for locally advanced pancreatic cancer. BfArM’s feedback was positive and gave regulatory clarity on key program elements, including clinical design, dosing plans, patient population strategy, nonclinical data needs, and CMC/manufacturing considerations. The written guidance supports the acceptability of the proposed study based on available safety and manufacturing information.
Silexion plans to use this advice in regulatory submissions to the Israeli Ministry of Health by the end of Q4 2025 and in Germany in Q1 2026, aiming to start the Phase 2/3 trial in Q2 2026 pending approvals. The company says the BfArM response is an important milestone as it completes manufacturing readiness, integrates toxicology data, and prepares clinical sites.
Read Announcement- Drug:
- SIL204
- Announced Date:
- September 30, 2025
- Indication:
- Across Multiple Cancer Types Beyond Pancreatic Cancer
Announcement
Silexion Therapeutics Corp announced that SIL204 has demonstrated activity against eleven human cell lines originating from 5 different organ cancer sites, each with a specific KRAS mutation.
AI Summary
Silexion Therapeutics Corp. announced that its experimental drug SIL204 showed strong activity against eleven human tumor cell lines from five organ sites, each carrying a specific KRAS mutation. The cancers tested include lung, colorectal, pancreatic, gastric, and other gastrointestinal tumors. SIL204 targeted eight major KRAS variants (G12D, G12V, G12R, G12C, G13C, G12A, Q61H, and G13D).
In lab assays, SIL204 achieved between 83.5% and 99.7% inhibition at very low (nanomolar) doses, with IC50 values ranging from 23.4 to 105 nM. Key findings include first evidence of gastric cancer activity (89.2% inhibition in G12D-mutant SNU-601 cells), expanded colorectal validation (105 nM IC50 in G13D HCT-116 cells), and strong pancreatic G12R targeting (91.5% inhibition).
These results confirm SIL204’s potential as a pan-KRAS therapy across multiple solid tumors. Its broad mutation coverage and high inhibition rates support further clinical development as an RNA interference treatment for diverse KRAS-driven cancers.
Read Announcement- Drug:
- SIL204
- Announced Date:
- September 11, 2025
- Indication:
- Across Multiple Cancer Types Beyond Pancreatic Cancer
Announcement
Silexion Therapeutics Corp announced new preclinical data demonstrating that subcutaneously administered SIL204 successfully reaches all primary sites of pancreatic cancer metastasis and shows anti-tumor activity.
AI Summary
Silexion Therapeutics announced that subcutaneous injections of SIL204 reached all major pancreatic cancer metastasis sites in mice. The study confirmed drug distribution to the liver, peritoneum, and lung at clinically relevant doses. Within a week, tumor signals fell significantly across these organs, showing strong anti-tumor activity.
Metastatic spread causes over 80 percent of pancreatic cancer deaths, and patients often see the disease return in distant organs. SIL204’s systemic reach supports Silexion’s plan to combine subcutaneous injections for spread disease with intratumoral dosing for primary tumors. The study used human KRAS G12D mutant cancer cells to reflect the most common oncogenic driver.
These findings validate Silexion’s dual-route administration and pave the way for Phase 2/3 clinical trials in early 2026. Tumor reduction at human-like doses gives added support for testing SIL204 in patients with aggressive KRAS-driven pancreatic cancer.
Read Announcement- Drug:
- SIL204
- Announced Date:
- July 31, 2025
- Indication:
- Across Multiple Cancer Types Beyond Pancreatic Cancer
Announcement
Silexion Therapeutics Corp announced groundbreaking new preclinical data revealing unprecedented inhibition rates of up to 97% in pancreatic cancer cells and almost 90% in colorectal cancer cells.
AI Summary
Silexion Therapeutics Corp. reported new preclinical results for its siRNA drug candidate, SIL204, showing up to 97% inhibition of pancreatic cancer cells and nearly 90% inhibition of colorectal cancer cells. In a Cell Titer‐Glo study, SIL204 achieved dose‐dependent inhibition of up to 94% in pancreatic cancer cells with the common KRAS G12D mutation and matched that efficacy—97%—in cells carrying the less‐studied KRAS Q61H mutation. It also blocked almost 90% of colorectal cancer cell growth driven by KRAS G12D.
These findings provide the first direct comparison of SIL204’s potency across multiple KRAS mutations and tumor types in one study. According to CEO Ilan Hadar, the high inhibition rates highlight SIL204’s promise as a pan-KRAS therapeutic. Silexion plans to start a Phase 2/3 clinical trial in the second quarter of 2026, using both intratumoral and systemic delivery to target KRAS‐driven solid tumors.
Read Announcement- Drug:
- SIL204
- Announced Date:
- July 9, 2025
- Indication:
- Across Multiple Cancer Types Beyond Pancreatic Cancer
Announcement
Silexion Therapeutics Corp. announced new positive preclinical data demonstrating SIL204's significant efficacy in human lung cancer cell lines.
AI Summary
Silexion Therapeutics Corp. has released new preclinical data showing that its product, SIL204, is significantly effective in human lung cancer cell lines. The study demonstrated that SIL204 produces a strong, dose-dependent inhibition in lung cancer cells with KRAS G12D mutations, suggesting it could become a valuable treatment for lung cancer patients. The findings highlight the importance of SIL204’s lipid-conjugated delivery system, which helps the drug enter tumor cells more efficiently. This innovative approach aims to overcome major barriers typically seen with siRNA therapies in solid tumors. Additionally, the company is planning to test SIL204 against a new KRAS mutation and is preparing to begin a Phase 2/3 clinical trial in 2026. These promising results pave the way for further clinical evaluation of SIL204 as a potential pan-KRAS treatment for challenging lung cancers.
Read Announcement- Drug:
- SIL204
- Announced Date:
- May 29, 2025
- Indication:
- Across Multiple Cancer Types Beyond Pancreatic Cancer
Announcement
Silexion Therapeutics Corp. announced compelling preclinical data demonstrating the efficacy of its next-generation RNAi therapeutic candidate, SIL204, against human pancreatic, colorectal and lung (NSCLC) cancer cell lines.
AI Summary
Silexion Therapeutics, a clinical-stage biotech company, announced compelling preclinical results for its next-generation RNAi therapeutic candidate, SIL204. The data showed that SIL204 effectively inhibited the growth and metabolic activity of human cancer cell lines, including those from pancreatic, colorectal, and non-small cell lung cancers (NSCLC). The therapy worked in a dose-dependent way, even at very low, nanomolar levels, which suggests it is potent in targeting the KRAS G12D mutation known to drive these cancers.
These findings broaden SIL204’s potential use beyond pancreatic cancer. By silencing the KRAS mutation at the RNA level, the treatment could offer a new approach to combat several aggressive and hard-to-treat tumors. This promising preclinical evidence supports the idea that SIL204 may become a valuable option for patients with various KRAS-driven cancers, addressing a significant unmet medical need.
Read Announcement- Drug:
- SIL204
- Announced Date:
- May 21, 2025
- Indication:
- Across Multiple Cancer Types Beyond Pancreatic Cancer
Announcement
Silexion Therapeutics Corp announced the completion of a comprehensive preclinical study assessing SIL204's therapeutic potential across multiple cancer types beyond pancreatic cancer.
AI Summary
Silexion Therapeutics Corp recently announced that it has completed a comprehensive preclinical study for its next-generation RNA interference therapeutic candidate, SIL204. This study expanded the focus beyond pancreatic cancer to include multiple KRAS-driven cancers. Researchers evaluated SIL204 in various cancer cell lines, including those from colorectal cancer, lung cancer, and pancreatic cancer. The selection of these cancer types was based on the high prevalence of KRAS mutations and significant unmet treatment needs. The promising results from these studies could allow the company to broaden its development strategy and offer a new treatment option for patients suffering from difficult-to-treat cancers. Silexion is now finalizing its data analysis and expects to announce full results in the coming days, signaling a potential new path in the fight against multiple types of cancer.
Read Announcement
SIL-204 FDA Regulatory Timeline and Events
SIL-204 is a drug developed by Silexion Therapeutics for the following indication: In advanced pancreatic cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SIL-204
- Announced Date:
- March 5, 2025
- Indication:
- In advanced pancreatic cancer
Announcement
Silexion Therapeutics Corp. announced positive data from orthotopic pancreatic cancer models demonstrating that subcutaneously administered SIL204 effectively reduces both primary tumor growth and metastatic spread.
AI Summary
Silexion Therapeutics Corp. recently announced promising preclinical data showing that its RNA interference therapy, SIL204, significantly reduces both primary tumor growth and metastatic spread in orthotopic pancreatic cancer models. In these studies, the therapy was given subcutaneously and demonstrated its ability to reach pancreatic tumors grown in the organ itself—offering a more realistic simulation of human disease compared to earlier models.
The new findings are important because they show that SIL204 not only shrinks the main tumor but also lowers the risk of cancer spreading to other organs. This suggests that a minimally-invasive, systemic delivery method could effectively treat both primary and metastatic pancreatic cancer, potentially offering a better treatment option for patients battling this devastating disease.
Read Announcement- Drug:
- SIL-204
- Announced Date:
- January 28, 2025
- Indication:
- In advanced pancreatic cancer
Announcement
Silexion Therapeutics Corp announced promising new preclinical data for SIL-204, its next-generation siRNA therapeutic candidate.
AI Summary
Silexion Therapeutics has released promising preclinical data for SIL-204, its next-generation siRNA therapeutic candidate. The new findings show that systemic administration of SIL-204 can effectively target aggressive KRAS mutations found in pancreatic cancer. Studies on animal models demonstrated that an extended release formulation of SIL-204 reduced tumor growth by about 50% in just 30 days, with nearly half of the tumors showing complete necrosis. Other experiments revealed that a single systemic dose maintained drug levels in plasma and tissues for over 56 days and that subcutaneous dosing inhibited growth in metastatic cancer models. The data supports SIL-204’s potential to address some of the most challenging cancers by targeting key mutations with prolonged therapeutic activity. Silexion plans to conduct further studies to evaluate its effect on metastases and refine its treatment strategy for KRAS-driven cancers.
Read Announcement- Drug:
- SIL-204
- Announced Date:
- January 15, 2025
- Indication:
- In advanced pancreatic cancer
Announcement
Silexion Therapeutics Corp announced new preclinical results demonstrating the synergistic efficacy of its proprietary second-generation siRNA candidate, SIL-204, in combination with components of first-line chemotherapy for pancreatic cancer.
AI Summary
Silexion Therapeutics Corp. recently announced promising preclinical results for its second-generation siRNA candidate, SIL-204, designed to target pancreatic cancer. The studies revealed that SIL-204 works well with standard chemotherapy drugs, showing strong synergistic effects when combined with first-line treatments such as 5-fluorouracil, irinotecan, and gemcitabine. Researchers tested the combination on human pancreatic tumor cell lines carrying the KRAS G12D mutation, the most common mutation found in pancreatic cancer, and observed a significant reduction in cancer cell growth compared to using chemotherapy alone.
These results suggest that SIL-204 could potentially enhance the effectiveness of existing chemotherapy regimens. The success seen in these studies supports Silexion's plans to further develop SIL-204 in upcoming clinical trials, offering hope for improved treatment options for patients with pancreatic cancer. The focus remains on targeting tough-to-treat KRAS-mutated cancers with innovative RNA interference technologies.
Read Announcement- Drug:
- SIL-204
- Announced Date:
- January 13, 2025
- Indication:
- In advanced pancreatic cancer
Announcement
Silexion Therapeutics Corp announced that it will be presenting a poster at the 2025 ASCO Gastrointestinal (GI) Cancers Symposium taking place January 23-25, 2025, in San Francisco, California.
AI Summary
Silexion Therapeutics Corp. recently announced that it will be presenting a poster at the 2025 ASCO Gastrointestinal Cancers Symposium in San Francisco from January 23-25, 2025. The symposium aims to highlight the latest science related to gastrointestinal cancers. Silexion’s poster will focus on their work with SIL-204 siRNA, which is designed to treat localized and systemic cancers with KRAS mutations, including G12x, Q61H, or G13D.
Dr. Mitchell Shirvan will present the research during a session dedicated to cancers of the pancreas, small bowel, and hepatobiliary tract on January 24, 2025, from 11:30 AM to 1:00 PM PST. The abstract for the study will be published on the ASCO Symposium website on January 21, 2025, at 5:00 PM ET, and the poster will later be available on Silexion’s website under the "Our Science" section.
Read Announcement- Drug:
- SIL-204
- Announced Date:
- October 1, 2024
- Indication:
- In advanced pancreatic cancer
Announcement
Silexion Therapeutics Corp. announced new preclinical findings for SIL-204, its second-generation siRNA candidate, following the optimization of its extended-release formulation.
AI Summary
Silexion Therapeutics Corp. has announced encouraging preclinical results for its second-generation siRNA candidate, SIL-204. The new data reveal that SIL-204, which has been optimized with an extended-release microparticle formulation, can significantly reduce tumors in pancreatic cancer models. In studies using mouse models, a single dose of SIL-204 showed strong anti-tumor activity, effectively targeting KRAS mutations—specifically the KRAS G12D mutation common in pancreatic cancer. This breakthrough is promising because it could lead to a treatment option that not only reduces tumor size but also causes tumor necrosis without daily injections. These preclinical results mark a significant step forward as Silexion plans to progress to toxicology studies and eventually initiate Phase 2/3 clinical trials by 2026, potentially changing the approach for treating aggressive KRAS-driven cancers.
Read Announcement
LODER FDA Regulatory Events
LODER is a drug developed by Silexion Therapeutics for the following indication: In patients with non-resectable locally advanced pancreatic cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LODER
- Announced Date:
- September 24, 2024
- Indication:
- In patients with non-resectable locally advanced pancreatic cancer
Announcement
Silexion Therapeutics Corp. announced significant new findings from its Phase 2 trial of LODER™ in patients with non-resectable locally advanced pancreatic cancer (LAPC) which bear the KRAS G12D or G12V mutation (approximately 70% of pancreatic cancer patients).
AI Summary
Silexion Therapeutics announced important Phase 2 trial results for its LODER™ treatment in patients with non-resectable locally advanced pancreatic cancer carrying the KRAS G12D or G12V mutation—mutations found in about 70% of pancreatic cancer cases. The trial revealed a 56% objective response rate (ORR) among treated patients. More notably, 67% of patients experienced enough tumor shrinkage to allow surgical removal, converting previously non-resectable tumors into resectable ones. This improvement in resectability offers significant hope by increasing the number of patients who could potentially benefit from surgery, a key factor in better long-term outcomes. These findings highlight LODER’s potential as an impactful treatment option for hard-to-treat pancreatic cancer and strengthen the company’s approach to targeting KRAS-driven tumors.
Read Announcement
